Earnings call transcript Q2 2023

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Secod Quarter 2023 Financial Results Conference Call. My name is Tawanda and I'll be your operator for today.

As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations.

begin. may You

Susan Hubbard

and the Tawanda, call. all joining for Thank second thank quarter for Exelixis conference XXXX us you, you financial results

Scientific Joining Officer; Chief are CEO; me of Commercial; our call our our President Goodman, on us and XXXX. Chief Aftab, our President Scientific quarter XXXX second Executive the Chief Mike our Peter our Vice Chris of for Lamb, progress the Vicki Officer; Medical join Officer, Financial Morrissey, our Dana who the Strategy EVP portion Q&A of June for P.J. will XXth, and Haley, Senner, will review call. today's ended

During the GAAP as posted well website using measures for accounting not accepted principles. measures, measures call Please our those from such our an refer non-GAAP explanation on financial our of press today, reasons is will making to for as according which generally be calculated deriving to today's results. tables we release

regarding making of During includes this course and statements discovery, company. possible the performance statements the and product will about This commercial, developments presentation, be the strategic regulatory, financial, of regarding future forward-looking future development, we matters. events

with development, level collaboration conducting competition, regulatory activities. the and of or trials, risks you the to applicable We from without review expressed that factors we results differ materially. today, Actual results compliance actual development to writing to of and the time related on SEC, costs by product course product materially processes, and partners, our success, time limitation, including those business Factors, filed refer from which uncertainties clinical the dependence verbally requirements, important regulatory commercialization in identify events documents with the to commercial and under discovery, could Risk differ heading could approval and associated market company cause with

And call I to with Mike. turn will over that the

Michael Morrissey

expedite a franchise, Exelixis the cabozantinib of the and while strong everyone development our us and discovery pipeline quarter at across thanks Thank to for had cancer goal components a the future, on of more all of All pleased of continued programs to second range the today. with see call to Exelixis of Susan, time growth joining we business. same right. helping many We're patients. the you, the build

Key include, highlights for the monotherapy IO/TKI continued market strong second-line for second US. with maintained revenue segment. of its cabozantinib the in-demand both business leading RCC status in the first, performance the and as quarter CABOMETYX the growth in the TKI and first-line

$XXX year-over-year XXXX product by quarter to franchise $XXX cabo compared approximately approximately and XXXX. of second grew the year-over-year product the and second XXXX. cabo were grew revenues also quarter were Global of Second XXXX, to XX% partners and net its XX% second quarter US million in net Exelixis compared quarter generated revenues million in franchise

quarter in Chris commentary will and the additional update PJ our commercial activities. progress on and provide our financial and

priorities is of medical to R&D populations pipeline and of patients unmet large top EXEL's commercially differentiated need. Second, in for clinically medicines high cancer with deliver a

we value standard-of-care to we more healthcare and shareholders. Our their providers for singular our More patients cancer. help, for create is patients improve with the patients, goal families,

an move small integrated to and have molecules. biologics They activities the We pipeline a development patients. and of drug potential and are cancer spanning significantly commercialization needle developing R&D have strategy for discovery, the

to New efforts quarter in Xnd, later event on at our announce progress call. Dana investor that second in City. and an our the R&D we'll highlight will pleased Vicki present York I'm December

clinical opportunities Third, tumor the to to activities continue generate indications. we clinical assets access to development seek remain as differentiating a solid business data with potential priority in

these of to transactions, this in to fortify product while closing is there guarantee success and several portfolio. approach our continue We have late-stage look discussions we ongoing no using

where litigation license Xst, XXXX, and Exelixis resolve January and the type. the market patent agreements fourth, Teva on of license to its beginning into generic exceptions and conditions if a a settlement by in of grant Finally, this US version entered common to with CABOMETYX Exelixis approved agreement will to to FDA Teva subject

and case in which MSN Our squarely resources to on focused the remains October. attention second trial goes

We intellectual rights. to continue will vigorously our protect property

with ago quarter. our an press please highlights release list financial of So key results in extensive that, our issued see quarter the corporate second hour an for and achieved

turn now to call I'll over Chris. the

Christopher Senner

Thanks, Mike.

cabozantinib company franchise $XXX.X quarter reported approximately revenues second of which million, the total XXXX, revenues million. the net For of $XXX product included

product revenues $XX million included and in trial net were approximately CABOMETYX $XXX.X clinical million, sales.

expect a we this been quarters choppy to reminder, sales future between clinical historically in have continue and quarters. As trials

franchise for experienced are Gross expenses. of assistance we This gross in XXXX. co-pay of is related cabozantinib gross of to the deductions of XXXX we quarter is lower the net lower to XX% primarily on second Part-D in which projecting net and between be XX.X%, net was to decrease to to XXXX XXXX. the half gross Based the and quarter will XXXX, net to in first XX% in net full for quarter the in second the year gross the first Medicare our than

$XX territories. by compared from $XX and to of Takeda of Our included the on of quarter cabozantinib also XXX Total XXXX. CABOMETYX royalties sales units in respective trade earned including their revenues, first approximately collaboration when million in inventory million revenues Ipsen approximately their approximately decreased

$XX in milestone we earned Additionally, Takeda million. cumulative above billion of sales achievement quarter $XXX an second XXXX, for of the net from their

driven million in to operating second approximately of costs quarter XXXX. quarter SG&A first $XXX quarter was related XXXX, sequentially total to for million second operating XXXX XXXX associated proxy higher $XXX contest. which with the of were The total increase in compared the expenses primarily the in expenses the was Our by expenses

quarter XXXX approximately income XXXX. for approximately first was provision the taxes quarter compared million taxes the for second for a million for $X.X Provision to $XX.X of income of

also $XX.X reported income $X.XX company per reported The non-GAAP for company of of quarter share approximately basis. income or of fully-diluted of Non-GAAP tax million fully million impact net of $XXX.X share income the excludes income $XX on basis a the or of net approximately net The XXXX. compensation approximately expense, $X.XX net GAAP per million second the stock-based effect. diluted on a related

discovery through to in Cash for June program XXth, pursue of this opportunities announced provides flexibility internal billion. approximately by share our return This the pipeline, ongoing repurchase invest and $X.X and activities, external the from $XXX ended business to Exelixis investments our cash to development with shareholders us million in of we cash to supported operations to XXXX investments, March and flow level year. quarter allows our expand capital the was

$XX.XX. we of million repurchased During $XXX the shares average at XXXX, quarter Exelixis' an approximately second price of of

a days after activity quarter first commenced committed on second We our repurchase to remain million on executing May earnings $XXX release program repurchase The few year. the quarter this share Xth. share fully

year our reiterating on XX XXXX is of financial guidance, are slide we which earnings presentation. our detailed finally And full

I'll now turn PJ. the call over to

P.J. Haley

you, Thank Chris.

cabozantinib to the of strong The team line quarter for high the at XXXX and RCC number HCC. in TKI franchise. continues The in one resulted was a level, a to execute has continuing prescribed be second which second quarter CABOMETYX

in in CABOMETYX carcinoma. TKI nivolumab one Additionally, line combination with combination remains first number plus cell renal the IO

by in this CABOMETYX XXXX. TRx grew QX of In QX relative TRx QX for volume X% the year. in business, volume CABOMETYX grew to X% to year-over-year terms compared XXXX, QX

market marketplace the strong share both again quarter. demand and and led CABOMETYX perspective. TKI in perform starts at in basket CABOMETYX QX to continued second competitive well XX%. in remains patient TRx new a Additionally, from

previously, we market with line in As competitive the with this RCC discussed have we performance and CABOMETYX the nivolumab are extremely first in is of pleased combination setting.

RCC prescribed number practice TKI one broad which risk is third quarter CABOMETYX was QX plus plus Uptake and in was in combination the nivolumab full RCC. first settings. a clinical line first groups across line in IO

Importantly, seen to in data. and efficacy, consistent is the which of life continue the report experience balance CheckMate prescriber - physicians of quality a positive safety with XER

were great continue for and perceptions very ASCO XX was which to highlight These XER CheckMate the a promote to productive month at - opportunity long-term and up a for reinforced provided follow Exelixis data. meeting us

may survival arm the XX XX.X hazard overall of representing months improvement a ratio is You of plus the recall, nivolumab an for months, over X.XX. CABOMETYX with sunitinib, comparator median

TKI data IO terms Furthermore, their of quality and to of are tolerability using relative prescribers competitors life. efficacy, data of in clinically also combination the the differentiatig is believe data these support and The meaningful. overall safety, experience view the compelling the survival physicians that who plus

this stay on balance to and enable the longer achieve believe therapy of that data discontinuation Prescribers low results. patients nivolumab plus rate these CABOMETYX to of

data with reinforce that Additionally, data the evidence RCC the of these position CONTACT-XX presented cabozantinib monotherapy, marketplace. reinforces at results body regards the to leadership the in the Collectively controller. strong the has CABOMETYX given of ASCO cabo

CABOMETYX from the data in We continued team ensure opportunity position that entire for every benefit to believe works our as growth cabo. momentum appropriate have patients day to these

I'll turn call the with Dana. that, to over And

Dana Aftab

All right. Thanks, P.J.

strategy capabilities overall both our discussed I and of on to is the May, in call drug earnings strength address targets. last priority for targets molecules the prioritize which to during leverage based to So discovery internal the biotherapeutics discovery highest and the for science small designed

as a new development going the current I'm compounds for as go in filing in Today, detail the more bit towards to we're of INDs the regarding where nomination progress into terms of pipeline development at well compound.

conjugates monoclonal reminder, as primarily on bispecific antibodies biotherapeutics as As a focused well our innate programs and antibody-drug are targeting brief immunity.

level several several all types biotherapeutics various have years. of the over partnerships contributed that of specific technologies, strategic internal leverages linker which supply past discovery significant and payload a Our team of antibodies to productivity

lethal KRAS selection in opportunities is target pursuing synthetic patient which index. best-in-class are not discovery results and programs attractive a to in targets clear achieving limiting present this therapeutic straightforward the strategies good because like ourselves molecule drug, we're patient apparent. primarily some in are drugging on we're selection where focused approach and dominant drivers small they and them towards typically Our oncogenic are But cases,

with Three compounds cabozantinib progressing which filed These be biotherapeutics are here toward is in IND XXXX. year the pipeline of as were last highlighted the filing. assets bottom. declared four to development expected So the preclinical and beyond at are

a is IND the and reduction anti- to be technology and for which first improvement targets the payload. file free these in we antigen will tumor XBXXX, in expressed advanced site-specific the payload broadly tubulin most expect XTX, for pharmacokinetic XBXXX Catalent's result, antibody-drug next-generation TAK uses compared conjugate competitor. conjugation and delivers a cytotoxic linker shows that and proprietary conjugate to antibody-drug payload The as

control or five the all full represents we chemistry have CMC. for manufacturing of responsibility first and also oversight that and of XBXXX stages had therapeutics

the leaders highly team our I'm aware, that CMC likes scientists you of many and is which process managed are say and to As complex, sure manufacturing Merck, has antibody-drug experienced comprises happy Novartis process the and expertly highly XBXXX. for AstraZeneca, I'm for from of internal that conjugates Genentech,

material IND our for delivering file us toxicology that and on next GLP-compliant to around year underway which the GMP for are we program study Our track will enable mid-XXXX. is

designed the to the and known and with combined programs of robust complimentary The is a expected these killer the NKGXA, simultaneously cell checkpoint checkpoint. a act natural is first-in-class PDLX cytotoxic T-Cells NK address of killer a immune IND activity inhibition bispecific pharmacology of cell that to promoting from innate and both XBXXX, cells. cell adaptive of second tumor activity natural for engager, antibody XBXXX as inhibition

to We is to targeted are in be renal IND for expect -- filing and second the that targeting immune alone. inhibitors, PDL lung tumors it first-generation of such the program active PDX XXXX. sensitive pathway checkpoint half in as This

XBXXX. site-specific in on inhibitor The targeting track Topoisomerase linker a next-generation uses and of third that late technology a payload program filing X targeting IND on expected Catalent's also follows microtubule and XBXXX, XBXXX. payload filing an the reach antibody-drug XBXXX for payload instead from to is tissue is on IND XXXX. program carries This conjugate factor conjugation

program Finally, is in carries more of CDXX, inhibition slowly same combines the is than move we to XBXXX experimentation safety that filing. others a safety macrophage progressing PD-LX a present and observed forward an This arm is predicted we due potential antibody which determine complementary checkpoint. with modeling testing, that if an non-GLP a to IND with have XBXXX to bispecific required the targeting toxicology acceptable, additional signal in margin

year. stages at In nominate biotherapeutics, molecules maturity, addition this both development to to these and we earlier small in expect discovery which from programs have of multiple programs, we compounds

pathway stated substantial currently will include which molecule year, patient development are need. and populations a new goal synthetic antibody small this for reach up a novel of compound to track targeting monoclonal addressing on antibody drug to We unmet checkpoint our five lethal well-defined immune conjugates, with new targets potentially

live potential these the programs or toward patients approaches to mission represent cancer of and All contribute our helping stronger have meaningfully first of and best-in-class recover longer.

And over the with call turn that I'll Vicki. to

Vicki Goodman

dose cabozantinib will as Today a this Dana. continues focused escalation the focusing stage Zanzalintinib I provide and year. of registrational on on the our well as decision on updates Thanks, most our and we XBXXX, advanced reaching XLXXX pipeline, progress in trial. program go-no-go later clinical are

focus approach retain outcomes for the goal trial the As a with to we rapidly our execution of pipeline pipeline advance assets, ultimate clinical refine cancer continue to molecules strong each of our patients. we strategic improving for on

Zanzalintinib, call, a we entered fully I'll tyrosine activity responses full both cell patients kinase naive pre-treated last robust pre-treated shared of earnings our inhibitor, in with development carcinoma with last next-generation from results year. cabo begin our cohort for enrolled which On demonstrating cell patients. XX renal and cabo STELLAR-XXX top-line clear

details to These as tumor support data medical An Zanza for upcoming evidence RCC submitted type complete in an and data inform conference abstract activity leveraging they Zanzalintinib with for a to the the sensitive we'll provide cabo available. and dataset additional of development provide further been become the cabo has share program.

several the plus and on other mature. of STELLAR-XXX, the for triplet cohorts expansion they escalation nivo doublet and the novo combination cohorts enrollment as established dose we In recommended enrollment We dose. have and now STELLAR-XXX and to have on a relatlimab of plus data forward completed cohorts is ongoing zanza Zanza sharing completed looking enrollment also the

advancing will inform is and from cohorts. registrational future plans expansion into multiple now zanza. combination tumor Data solid for STELLAR-XXX This STELLAR-XXX

studies. Turning MMR high, now Phase STELLAR-XXX in Regorafenib the proficient to late-line cancer. Atezolizumab III our versus colorectal of with patients combination zanza non-MSI with Zanza compares

which IO/TKI amending metastases data versus based that without appear the presented to liver liver baseline last including from with to emerging combinations trial Zanzalintinib at benefit patients compared IO currently subjects the plus are We cancer at colorectal combination data, Pembrolizumab of more ESMO at trial GI LEAP-XXX month, for standard-of-care including derive mets on suggests baseline.

Phase liver of will metastases. of RAS a patients trial XX% to of be recent status regardless appears the patients XX% be with on XXX late-line including of similar patients. design, metastases amendment total liver CRC around prevalence the without III In Based performed in metastatic and approximately settings, enrolled to and

mets or if possibility comers, primary will presence Stratification in-patients presence primary to to mets likely of the patients mets, already not which all the benefit. in which liver will overall includes positive. OS benefit be will be tested success most statistically the endpoint factors, secondary with change. survival endpoint OS focusing increasing is analysis the preserve demonstrate probability This irrespective liver while the liver The by the of primary in the on of absence of without of the will patients

who combination STELLAR-XXX, metastatic a for zanza of patients treated the not Phase trial non-clear sunitinib previously cell nivolumab also III in and disease certain to comparing enrolling. with have RCC histologic is been subtypes

we With these the initiation year. additional for now two trials track Phase Phase III this of IIIs on underway, are also

STELLAR-XXX, patients carcinoma to are in or next pembrolizumab Phase Zanzalintinib neck. evaluate and combination announce II/III, will positive a PD-LX planned We first-line registration-directed in the pembrolizumab alone head study, pleased our with versus cell squamous with which metastatic recurrent of

received based approval on overall enroll single agent Pembrolizumab XXX endpoints. will a study this dual The in OS PFS survival. and are primary approximately as patients and setting

With emerging for objective XX% comorbidity. for well have response trial seen than in population opportunity in tolerable multiple fewer to outcomes Zanzalintinib, an this as profile that for an patients However, may investigator-sponsored regimen a setting, safety a this this improve provide response. cabo five with with rate versus in pembro we single-agent the as an is favorable believe one

which conjugate, tissue targets first drug Moving to XBXXX, our on antibody factor.

those cohorts. tumors, dose been for We along to on expansion a to first solid now optimization to FDA's recommended has that enrollment. and in expansion carrying share Optimus we patient with are have into one dose now cohorts Project I'm dose, fulfill are of open which now established the dose dosed lower that a multiple pleased requirements

These efficacy pivot signal will safety inform to profile us drug cohorts and and quickly into allow registration-directed the trials. detection

combination to sensitive continue bevacizumab to dose to to we will Additionally, combination the enroll promising with carry each cohorts recommended and nivolumab approaches and into forward other a combinations out in on continue expansion, types. dose for escalation seek tumor we determine

we in cancer CONTACT-XX, endpoint in expect prostate III primary combination the for metastatic atezolizumab survival year. the our Phase study For of castration-resistant this progression-free cabozantinib, with readout

COSMIC-XXX also track this OS for The second is on analysis for year. interim for

In summary, continuing the Zanzalintinib both believe advancing at conferences make expedite assets upcoming to benefit we We for emerging with molecules look are our they the encouraging. data pipeline continue emerging development data that to to sharing as the forward mature medical progress XBXXX and the and promising of these patients and of for cancer.

I'll turn that With Mike. over call back to the

Michael Morrissey

Vicki. right. All Thanks,

and in all across we more our to pipeline great as call have at excited future. at Exelixis We patients look latest the drive off our on sharing is cancer in to to day start plans the growth increased heard any discover help and We're the work you the December. forward our cabozantinib business components a results from As of today, momentum our to of we as XXXX. develop R&D franchise pipeline Exelixis

I'll efforts close longer. to collective patients our for live their cancer commercial The team our recover to mission and by development thanking help stronger the Exelixis achieve highly to team motivated support is activities. discovery, and

our We we're call a now future. in progress open collaboration. happy for drive support forward and you results build single urgency Exelixis you and and interest for questions. of to on day innovation purpose in the Thank and your with our to continued foundation We the to every on updating look

Operator

from Thank the you. line [Operator Instructions] Truist. first Our Goonewardene of with comes question Asthika

is line Your open.

Asthika Goonewardene

and Hi, for guys. thanks taking my Good question. afternoon

team want questions a Good to got just of I that. quarter of First another growth. I congratulate guess revenue off, to see on bunch the I consistent Vicki. for

a you enrollment might got so have your here us STELLAR-XXX I cohorts of the you expansion escalation expansion be then on And couple completed which completed I've slides and tell dose follow-ups. far. several able for was to if mentioned you've on Vicki, study, I that enrollment you So cohorts. wondering Phase

Vicki Goodman

Yes.

yes. So --

that a my cohorts. be on We'll mentioned remarks details the to in share that prepared as completed So enrollment we've mature. number I as more on data of

that our for on Clear shared but seen you've not call also which had the earnings had assessment. data the adequate cohort, make think RCC I to an follow-up only completed we last cell enrollment,

more So come on to that.

Asthika Goonewardene

cohort? ESMO, maybe just sorry, at they you then cohorts data And at it. meeting this have Got will later medical a one presenting multiple or year, where be will

Vicki Goodman

Yes. both Those patients. the including data, that are specifically safety point clear data RCC to XX cell cohort, clarify We'll presentation. updated have and the efficacy in that

Asthika Goonewardene

Got it.

patient last in in then, the was end since zanza, And earnings unconfirmed what last zanza, be I might exclusively that you the who triplet up and that that if May. Okay. XX% to in had does or becoming it chance a as nivo, was guess, confirmed STELLAR-XXX mentioned And I the zanza, XX% And include also at call, -- ORR. one ipi and nivo a able mentioned you you spoke study, Did then, wondering, time PR? that we any if is the rela us tell that you the you well? patient

Vicki Goodman

Yes.

efficacy the in we'll again, So share data presentation. the updated

an safety So as get response data. again, updated you'll more well the details on rate as,

expansion as with cohorts rela-triplet STELLAR-XXX, we zanza advancing make they and into ongoing different for cohorts combination the the have now for nivo, types. we're different tumor As in sense in

Asthika Goonewardene

I color. Got the it. All lot. right. all Thanks appreciate a

Vicki Goodman

Thank bet. You you, Asthika.

Operator

Please for next our you. standby Thank question.

of of from with comes the America Gerberry question next Our Bank Jason line Securities.

open. is line Your

Jason Gerberry

my questions. Hey, thanks taking for

Just two for me.

anything like from you then directionally it of that cost deal just if cost? Just around IRA you Teva on the Just very there's positive for of looks MSM, is to donut proportion that you that a implications your trying lead you're roughly Thanks. And gross XX% Wondering better and big and net the deductions you pricing. catastrophic on coverage cabo slightly could to favorable a in guys sense giving precludes cabo, -- get hole challenger, like the guys. quickly that, settlement wondering -- roughly, announced, terms? if a

Michael Morrissey

I'll Yes, and Jason, Chris the gross with help can thanks the speak the settlement. for to questions. Teva to net,

Christopher Senner

perspective, higher roll The catastrophic, QX, All hole as right. a about big the year, many gross do them -- -- the patients Jason, piece of donut those it's net. not and we piece hole roll prior necessarily when they but cabo that the through is Chris. they of hole has we've as the before, donut to -- see to the current impact we on have in being From roll year a year. from net over we gross talked donut we just do through over roll particularly when to because

donut and hole necessarily So side a not things. of the lot of on catastrophic its

Michael Morrissey

on surprise as -- question that you, then And a regarding on the in on won't I'm low to comment detail probably Teva, to somewhat be settlement. much

or that in certainly Teva say we our been I relatability January date that's the would got going we Xst. settlement very think going sending have to things the pleased IP the XXXX. we're settlements some other of into And action aggressive very in messaging So continue time. the do might future, forward. to obviously, And to of over we're with about I we've other consistent to be protecting

much the So would two but imagine, say how you as would can't about really interact.

Jason Gerberry

Had to try.

Vicki Goodman

Thanks, Jason.

Operator

you. our Thank for next standby Please question.

next Our Michael Guggenheim. Schmidt with of the from comes question line

open. Your line is

Michael Schmidt

guys, in this you I endpoints Hey, indication? had on second a data. for opportunity obviously for thanks on CONTACT-XX have potential for need for file the therapy to And follow-up. just both questions. Could this had based endpoints file PFS population? would then study the to bigger bar second PFS in for or what PFS a OS, you order is -- dual taking hormone is us there you And my upcoming picture and remind one I

Vicki Goodman

for the thanks question, Michael. Yes,

who So non-hormonal with have cancer received already of these patients castration-resistant terms in metastatic the prostate bar, again therapy. are first

the So has their they somewhere short on of second advance given PFS X.X to months PFS. line have about actually which in chemotherapy, not order of to tend quite on X NHC so

conversations is, say appropriate, evaluate totality benefit data, going those that PFS have we would come in, if What authorities. profile and in of the of or risk see of overall as they to terms the OS? would the on terms we In the we're we'll file alone with I regulatory

Michael Schmidt

additional your the then efforts and And on thanks. pipeline for activities. detail thanks Great, R&D

your so To more investing pipeline what your degree still affect clinical advancing the you that priority on development Thanks shifting much. now more focusing balance Or strategy? you're this point business capabilities? does internal into development. at programs given obviously a Is sheet? towards strong that into are So internal

Michael Morrissey

Michael, interest continuing Yeah, intro our my activities question development and to new priority a access no, that. we a for We Yeah, the it's around Mike. and business BD clinical added assets. thanks bullet specifically in in that's and great have our

So that's still progress priority we're agnostic I out a conviction R&D a Again, our there for us. high molecules lot, there's from. we're to wish a come of assets efforts, to that make lot some but on where internal that we like pursuing.

that's important it's process. now. And of but again, our So to able main complete no transactions, us focus be a guarantee an part still those will for certainly right

Michael Schmidt

much. Great. Thanks so

Vicki Goodman

Thanks, Michael.

Operator

standby Thank our for question. you. next Please

line Hsieh of Our the Blair. next question comes from with William Andy

line is open. Your

Andy Hsieh

Thanks got for our couple questions. a taking here. I

about the about update about wild at liver curious that a dependent kind two-by-two mutated just on for mets. STELLAR-XXX Vicki, the this study. the So, I'm of metrics. two or emerging Just variable thanks Is status, observation that type? whether curious regarding RAS it's

Vicki Goodman

Yes, thanks for question. the

bit primary as the the type have So enrolling overall survival maybe a to without detail regard patients, just we the did there, current to little RAS STELLAR-XXX patients will design clarify wild a design, RAS under amended so status. of be endpoint, in

the of analyzing the change data really status. we're be based improve probability on to trial emerging RAS that data. without the making regard success of will We is The to

where without dataset of the seen retrospectively combination, with presented terms regorafenib mets. nivolumab than to has response at looked rate. a approximately in ago, liver patients the been such liver month single-ARM IO were including So IO/TKI mets small some combination data and with patients higher And were and datasets in rates had response that, as we've what LEAP-XX prior there

Phase without had in was overall out the without negative LEAPXX response for that OS hazard progression-free those while the changed in in the a which read improvement the X.XX as so has OS -- patients a rate some ratio in survival we it mets X.XX. of hazard with population, liver ratio with in have data, was patients or whether liver survival. X.XX was what biggest overall the despite not the overall was predictor there analysis but trial for mets, liver subgroup So benefit now survival mets, in III The and or

believe that mets spoken key and that committee other endpoint. we of supports evidence data we've to population into weight a leaders, also now totality agree our moving as opinion the and our So non-liver the of is the steering primary the

trial, to from based that and we data plan secondary focusing to study for the the of opportunity emerging patients what probability likely that so. of primary to analysis ITC of external is include external own on us the are to and most all sure mets it this a our success benefit do, from liver and programs, regardless the an really an which do increased make therapy mets have with the opportunity to patients And patients again and again, on again, RAS analysis and liver without with is this so status. in comers and And would

Andy Hsieh

Got it. That's very helpful.

I'm solid you factor curious that positive just tissue factor potentially And there. a tumor agnostic think also, the how tissue Regarding how big about strategy is about regulatory opportunity, opportunity?

Vicki Goodman

Yeah.

exploratory be us which I to think other cohort specific is study, types we're give in about opportunity studying. to point, that tumor -- an outside it's types for on cohort. that all it studying tissue look us we're an at to This there. So paths regulatory really directed our tumor may too not gives help Based talk on us in at factor this we early indication for expression, looking factor this ones currently patients whether across response. It on appears of board the the in also identify are may that at predictive some tissue signals tumor expression,

Andy Hsieh

the for are what some your about on and data CBX-XX, lastly ASCO conditions us presented view maybe And Great. on at remind curious opt-in?

Vicki Goodman

see in the confirmed see in that dose activity we Yeah, we've so been assets. data safety escalation. profile emerging, have and and CBX-XX will cohorts to expansion optin have once the wait is of and responses the We're decision the really, to encouraged continuing the certainly

Andy Hsieh

Okay, great, thank you so much.

Vicki Goodman

Yeah, thank you, Andy.

Operator

Thank our question. standby for Please you. next

line Our comes Oppenheimer. from of Jay question Olson next with the

open. Your line is

Jay Olson

sales, and cabo for for strong quarter. And second if questions. growth, in congrats the the thank and had thoughts for you maybe Based a strong guidance just your quarter-over-quarter the original on is they hey, the And on at then some the keeping for on can growth XX%, pipeline what market? the rate I you Oh, could. in for I a rationale expectation half competitive the taking the follow-on, just TKIs comment market RCC maybe the share landscape on color had any on cabo

Michael Morrissey

and briefly Right. Chris can the Why P.J. part with about comment first. start Jay, market on we question guidance. thanks. that the talk second can then RCC dynamics the space, don't of in

P.J. Haley

thanks question. for the Yeah,

with TKI I the quarter to we third regards now combinations plus So the for market in market, row. line a as IO first the leaders in are mentioned,

of basket a lot market XX% TRx strength quarter. market, the So the share. increased quarter-over And in we're that in market there and

think strong I momentum. we So have

the perceptions data, from the were drive and starts from in I mentioned, balance really I seeing the particularly XX patient data combination, continues beyond demand our positive for -XER, growth both the what differentiating strong XX sunitinib survival data. which we're follow-up months that is CheckMate As and is the particularly the combination really overall data, -- we but of really the to data in seeing long-term at new and think follow-up we're months now

the we good in marketplace. continued momentum sort growth opportunity for our So about feel and Chris? of

Christopher Senner

Thanks, P.J.

from quarter. guidance just perspective, a strong P.J., a had from heard So as you we

we've think why we're the strong the have into we growth year, to first grow year the and seen the half we today. range half of the that ability that growth confident did we continue has to second guidance cabo of reiterated the based on We that's in strong and that

Jay Olson

on just do if pipeline you you CBX-XX at Phase away not Can how I a whether congrats Okay, be cohort ASCO. recommending comment II a or in the dosing could you and great, you'll a from far QXW thank question, on starting And you. dose? are data think squeeze

Vicki Goodman

Yeah, so, thanks the for question.

a We into multiple has cohort selection Project schedule, terms and Ultimately of moving that are in consider three of terms different FDA's weekly doses, here factors have requirements Cybrexa I now. ongoing the optimization. we dosing every and dose, to actually, dose there are think Optimus of of in

but like, selecting what with go making now we sure forward that exactly So that Cybrexa solid dose look on to have we're in a might foundation a discussions with. for

Jay Olson

taking the for Thanks questions. Great.

Vicki Goodman

Thank Of course, Jay. you.

Operator

stand by question. Thank next our you. Please for

line Our the JMP with Tuerkcan comes from next question Silvan Securities. of

is open. line Your

Silvan Tuerkcan

and please COSMIC-XXX supplemental the Thank can the we do What then if the a NDA? great you are I in scenarios follow-up And half second of from a data on get about, the question. I taking upcoming how questions have for quarter. my data scenarios to for the you question this outline congrats and with have of the kind year?

Vicki Goodman

a reported that progression-free endpoints data COSMIC-XXX, carcinoma. combination with we renal alone in clear nivolumab an the Yeah, nivo it survival with and in progression-free of year time, cabozantinib OS top-line data course, about for wanted any in cell so we overall of At versus the the and showed made they filing. FDA, immature conversations that poor ago considering they and Ipi results see improvement in-patients which just survival intermediate-risk were and prior to survival ipilimumab with for to

can is survival this and to -- the XXX, dependent, filing. to overall data and a could seem respect the data risk with consider favorable support a of next if benefit interim we So analysis

with discussion that FDA. have We

Silvan Tuerkcan

benefit Is there was a way a you that in I a of only differential on -- subset file versus medium-to-high-risk low-risk the patients? recall that could between that the patients

Vicki Goodman

data, about speculate filing on And have can't with FDA. on really potential I again that. the Yeah. based the we'll conversation

Silvan Tuerkcan

for thank question. so my much taking Well, you Great.

Vicki Goodman

Thank Of course, Silvan. you.

Operator

Please standby for question. next Thank you. our

Our Capital next comes of the Markets. line Etzer question Darout BMO from with

Your open. is line

Etzer Darout

of A taking pipeline. from the Great. sort question. Thanks from for couple both my me,

this liver could population. STELLAR-XXX, planned talk sort or performance whether then of of at wondered for you I And CPS be impacts or with First like of assuming IKNOTE-XXX at and am would than in if all. greater of that than group scores without performance the study, analysis you. CPS the PD-LX then primary and on the about regorafenib guess, the maybe be Thank not control with on greater the is mets will based that what the patients all STELLAR-XXX X I X

Vicki Goodman

Yes, sure.

take question first. the of are regorafenib, around X% very I XXX across-the-board. low, So mean response I'll rates kind

differentiation think in appears mets becoming response unmet really and perspective. look the much have in it's need for non-liver the there we probability don't the that's perspective, an really when non-liver that various from we increasingly from IO be IO of we the benefit patients. where think between And clear both an mets at again, combos, patient the outcome. to is successful So mets Again, see liver data we a I There populations. greatest a

So, unmet without we be Again, of and here there mets. terms liver liver a regardless benefit poor with to options are mets able to patients in of enrolling give standard-of-care. it's need an big with if us in to opportunity both show

again XXX, of terms setting. in approved in So, that is pembro

approved. which one. So or CPS to pembro low. the than quite survival -- greater population be however, demonstrated an here rates led the in which approval, overall was benefit as out to relative And are you equal we'll response in pointed standard-of-care, to the studying They

to last with believe again, with did there the believe we safety data to pembro response cabo we XX%, we're opportunity, Zanza's again, add that rate so. with do So at is we and here on presented were really the and of year that that, based benefit well-placed combination see ASCO profile, with activity those in

Etzer Darout

Great. Thank you.

Michael Morrissey

welcome. You're

Operator

standby Thank our next you. for question. Please

Our question the comes Wells Archila Fargo. Derek from of with next line

is line open. Your

Derek Archila

Thanks everyone. taking questions. the for Hey,

Just two us. from

help frame question, market And So earlier you any communicated? current And any be the with second identify can kind an the recent would cabo-atezo changes the maybe for on are base you pre-chemo of prostate? on to see question that then to setting in CONTACT-XX, in so, to opportunity piggyback the the efficiencies? combo the you. Thank -- plans Board, to when cost there if just review

Michael Morrissey

first CONTACT-XX? one to about you want the the for PJ, Thanks take questions.

P.J. Haley

regards to things have think about. of should approval and mean, a the data market, we be couple Yeah. I a with market. to positive we're excited I Certainly,

even second cancer very line -- is north and You market this say patients. of medical KOLs, just generally what setting, know that guess prostate need market kind research in and obviously large well chemo. conversations to speaking strong that CRPC with I and desire unmet I'd In things. is significant in and there's more setting, couple setting There is, of XX,XXX of delaying metastatic broadly there is a also plus

would of on in be think based setting. TKI that feedback extremely a and So, the well-received inhibitor I a combination gotten the we've checkpoint

certainly potential the opportunity. about optimistic we're So

Michael Morrissey

what the and been the In We've our for -- the patients pleased context now building the tactics, of a months. on and with a company, tone, value the of Board full strategically it's together value shareholders. tenure, again, for therefore really strategy met and context for building etcetera couple on collaboration, committees, Boards the tactically as In our both individually, we're doing have focused Mike, deliberations, around small Board, groups, focus

As you we we're eventually content can able about today's if our be towards where are pivotal and enable on agenda full real pipeline really the pushing traction in we're the R&D forward tell generating excited there clinically we to differentiating call, commercialization on by all to future going. in have our and data. trials And

depth So tuned. going the and opportunity lot today lot with we're balance very commercial sheet on to to relative room of Obviously, and the we've R&D. the the got stay about from And within you and maneuver Dana just that. us, and Vicki think there's excited strength a cabo a heard of we

Derek Archila

it. Got

quarter. on Congrats great. the Sounds Thanks.

Vicki Goodman

you thank very much. Yeah,

Operator

our Thank standby question. for Please you. next

line the Sandler. from comes question Catanzaro of Joe with Piper next Our

Your line is open.

Joseph Catanzaro

so here. much my everybody, taking questions Hey, thanks for

things. pipeline the side of on two Just

First one on XBXXX dosing.

So with on generated work some interesting three-week since done TIVDAK schedule But outside dosing. that approved data some the every of cervical.

wondering efforts SIRPalpha forward the you then consider which failure? you with second your recent And magrolimab space you in updated -- much how the schedule of with have in any light Thanks. -CDXX move wondering the So thoughts question, if XXX? just on

Michael Morrissey

the to the discussion question for some of for efforts. Vicki then and Vicki? around Thanks question. our can XBXXX CDXX for over Dana we'll pivot handle

Vicki Goodman

mg/kg dose in a mg/kg of into of we're the expansion X.X Yeah, -- lower forward taking requirements meet so in expansion Optimus. in to X.XX of order that dose again terms into XBXXX, the the with cohorts Project is

be we're to exposure TIVDAK I will note to board. And there profile at doing better think our PK We across respect response modeling the will I carefully. encouraging. understand the looked very what PK is dosing, with we've seeing

free kind is, lower to levels of auristatin which to two playing level not to terms One toxicity, off-target key dose. be safety of payload, the seems in to contributes substantially points. efficacy, as at of out TIVDAK free that of in So And the compared well. approved profile seeing the we're but

in our TIVDAK. lower of payload we X.XX, about dose chosen So five-fold have relative level to to higher

X.X compared above, threefold approved ADC and of the it's Intact case overall selected TIVDAK kilogram the to per and ADC, terms really we're X and correspondingly, milligram seeing impact In in the TIVDAK higher exposures seeing at at of than exposure X.XX, a of that higher mg/kg, doses dose we're at higher our dose. in

terms the exploring So low may safety really have in our profile, the of profile. doses a that move to really payload we and about differentiated efficacy to should the be forward but levels dose with Intact ADC the of quite of and now confident driving we're a while contribute both response help solid safety it's free

Dana Aftab

for Thanks on question the Dana. is CDXX. this And

any within mentioned, of trial -- was So lot in many a which trial didn't targets which or a announcements patients that make and magro other And array to high-risk other to large indications. They with on have programs they a that magrolimab recently announced futility. you Phase logic due MDS. their Gilead CDXX stopped as proceeding very III malignancy and Phase of X it's trial

strong in have So pathway. the belief we still CDXX a

as first-generation And XBXXX, immune clinical that prepared of as SIRP strong based the CDXX feel inhibition target of includes key immune agents Our combining a is most prudent, designed checkpoint on was aware, we CDXX rationale a a also mentioned remarks advanced on of action is with feel solid angles, like magro. it is a very adaptive PD-X/PD-LX, a targeting as multiple an agents and alpha, is approach in which preclinical inhibition know, the this which also that compelling you wheels Sairopa, of from pathway, important targeting known also carefully for which pathway of tumors, key mechanism alpha you're that we the which agents approach, I SIRP is this investing call with still in next-generation ADU-XXXX, profile really is can a selectively. checkpoint. including and next-generation potently We in multiple innate believe in

pathway. this target to strategy our on solid still we're So

Joseph Catanzaro

Great, my thanks for taking much so Okay. questions.

Vicki Goodman

you. Thank course. Of

Operator

for next you. question. Thank standby Please our

comes question Morgan the next Stanley. from of Jeff Hung Our line with

Your open . line is

Jeffrey Hung

have you an data? a follow-up. initial see and we Could for ADU-XXXX you update provide I X Phase questions. Thank study on taking then the my when And might

Michael Morrissey

Vicki? Dana or

Vicki Goodman

go to too it. that. on It's is the Sairopa early Yes, have when will ongoing We're we closely a presentation. that working discuss I'll so data in team dose-escalation. with

Jeffrey Hung

on free expect mitigate to then you And Okay. levels risk key Intact same in Thanks. XBXXX, the differs And the share of the given do to for they XXX adverse terms or similarly of maintaining ADC from payload? then, events, XXX is but goal XBXXX, targeting, selectivity? while that behave payload to

Dana Aftab

for the is Dana. question. Thanks this Yes,

be is any that So have early honestly again, too see inhibitor for also giving X same because to mainly but use inhibitors, clinic. payloads. we to differentiation technology. cancers to safety get anti-tubulin we traction sensitive payload. payload specific we of in seen, somerase It's X the to antibody excited carries about helped payload to it linker sensitive for the really are that anti-tubulin once on known which be that the the the But tell into remains XXX, next-generation very XBXXX, XXX are if in does will we are known Topoisomerase by payload be With the to of differences not XXX, be us site-specific

the where So wait data we'll strategy for that's and really the us. overall that leads molecule

Jeffrey Hung

Great, thank you.

Vicki Goodman

Jeff. you, Thank Okay.

Operator

Thank standby next for question. Please our you.

line Peter of Lawson Our the next comes question Barclays. from with

is open. line Your

Alex Bouilloux

good on for Peter. taking our questions. Alex is for Hi, Thanks This afternoon.

cash your you see to Just given internal your your Thank one, just and program increase position, buyback BD plans potential for investments, share you. do potentially?

Christopher Senner

Chris. the this question. for Alex Thanks is

share evaluate So in allocate how across of to commercialization committed as areas we'll and the development including capital we multiple R&D right repurchase, goes and now, potential share continue we million $XXX the -- we authorized but the also also March. on, And program, are business, to we repurchase got time

Operator

Thank you.

Vicki Goodman

question, Take operator. the next

Operator

Please standby next for our question.

Stifel. of the Willey from with line Stephen next question Our comes

is open. line Your

Stephen Willey

for Thanks afternoon. me squeezing in. good Yeah,

either proportion could bit get your And be any nine And Just will going status that protocol making arm to case. representation was the be just I control of know does just that I preferentially TAS-XXX underlying one than increase think enrollment included now amendments? contemplate attempt back there arm plus a completed speak the patients, change XXX, months enrolled guess to to many believe what the mets? a then, guess, to to better I the sample RAS can -- prior the size you liver of folks assumption? was higher would of control both which a I that I regorafenib emerge, kind in Thanks. in thought also and/or

Vicki Goodman

still -- enrollment, in of in going XXX a well. that's have been We're so activate. Yes, terms number sites still of to

to running, So patients that and have we're able quickly. relatively in be up roughly enroll even those confident once the we'll sites we additional increase XX%

have the already been the patients All relevant enrolled, to they patient certainly that population. of are

concerns again So we about incidents being coming liver any with the back high. patients skewing is don't fact to there metastases quite the any have of kind of driven patient by the increase The population.

to population representative, without. substantial patients that of incident somewhere order patient addition liver a have fraction in with to liver to looks mets those in near enroll have a of we mets, So the

the show how again, population, benefit So a can possibility been we preserving in have we've but in higher primary recruiting be will enroll again, analysis that time overall to the to number, to the of a benefit in some well a showing study. while smaller But we population, we make-up population. somewhat given smaller again, think the

Stephen Willey

the taking for Thanks Great. question.

Vicki Goodman

Steve. bet, You

Operator

question. Please you. next our Thank standby for

Goldman Sachs. Chris of line the from comes question next Our Shibutani with

line Your open. is

Chris Shibutani

to implications have lot bit for you. amendment planned out have any This for your the could program see. December going we'll It of sense us Can the Does effect just the data. potential the Phase Day the have disclosing can more when zenza additional pretty and R&D then across us III a And studies. or you much is give thank or guess are, to wait-and data more on across for December, little with Analyst to responses get in XXX seems broadly, help Day Great, the there wait clarify just just plans but you question. I timelines? Stephen's answer on I a we

Michael Morrissey

Okay.

first of So to take will take part second. I the the question. you want the preferred that

Vicki Goodman

longer that of the but we're relevant enthusiasm. so we've enroll. under we've mean, the patient size recruitment, some so patients course, a XX%, that Again, enrolled had still investigator we've I lots are expect will bringing take robust it to again, Yeah. the sites and still population remained increased by on-board, of do sample to already that we study,

think that can make-up we there. we ultimately So some time

Michael Morrissey

barely December. terms Day in of of want and It's That's I August. Chris, ahead far ourselves. get R&D content, agenda Yeah, to too the don't in

figure the we've data as it's historically, pipeline. time mature So we only spectrum, entire Obviously, cabo out. not have but some available when presenting across the that got committed to we're to

certainly with we'll mature to -- how certainly to in data as which we're on-track a data the it's somebody find designed case later to zanza with its be that do the the get will the that year and matures, that has year, we matures, So relative and this data have it that when this -- own out opportunity way course but appropriate.

your patience. So, appreciate

there. York, that we and right sheer, the this depth You will longer think of business understand greatest that morning a of I you on that some and across gotten fulsome like. understand long-time, just comfortable in you have R&D than development other collaborations New for very a you'd we've data the with and have and that are But we're we're been a things stuff these take so in latest when now with very discovery the working --

Vicki Goodman

Yeah.

question? Next

Operator

the for standby Please question. next you. Thank

Yaron Our Werber TD next question comes from Cowen. of line with the

line Your is open.

Yaron Werber

Maybe, call-out us? expanded items, maintaining just bit very-high. focus imagine your of study? Chris, you I patients low Great, and for first-half the first, new And of little specific couple for on you a us Any just with without clarify, got increase in taking I for then give the guidance. the power you you're now been thanks tax-rate of the Can kind can liver on to the has The of the with the a the the expecting sense are terrifically in of a tax-rate. question. you powering questions. sort STELLAR-XXX, you mets, secondly, is can tax-rate on second-half?

you. effect looking Thank So delta you're treatment what's for? or that the

Christopher Senner

Chris. it's Yaron, Hey,

right. you're yeah, So

first-half tax-rate that the a that lot year. below of look or of expenses year into has guidance go in things at the may not year entirety the range. some that But been of the when Our second-half of our the are may there there's and happen for you the is

guidance we're So our reason. for maintaining that

Yaron Werber

thanks. Okay,

Vicki Goodman

to for population overall respect as for the clinically in IGT. STELLAR-XXX, the a in power as in looking with both mets of survival, non-liver And terms well we're effect the meaningful

Yaron Werber

what bit. clinically you be if consider And a you expand do I can to don't little meaningful? know

Vicki Goodman

and survival LEAP-XX see getting what interactions as also they're non-liver for data think in with Without the into I again, the regulatory say, ratios, the as can to population. looking statistics, benefits, OS overall the hazard I just would well earlier they we saw terms for when we that in difference of have look as about mets agencies, with and the what mentioned you in payers

Operator

for Hubbard queue. now the call Susan Ladies closing and showing no turn I'm over to I host remarks. in Thank gentlemen, to questions your you. would further like the back

Susan Hubbard

all unable you have were We your during thank call. us address and Tawanda, thanks that for calls today. joining with any you we may Great, welcome to today's additional follow-up questions

Operator

and Ladies you. for Thank you Thank today's gentlemen, call. participation. your concludes conference this

You may disconnect. now

Exelixis (EXEL) 1 Aug 232023 Q2 Earnings call transcript